2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

The observation period has not been specified.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

EC Number:

216-251-6

EC Name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Cas Number:

1533-78-4

Molecular formula:

C22H24ClN5O7

IUPAC Name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Test material form:

solid

Details on test material:

Disperse Red 167:1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater, Manchester, UK
- Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: 2.14-2.71Kg
- Housing: individually in satinised aluminium sheet cages
- Diet: Labsure CR6 Rabbit Diet ad libidum
- Water: via an automatic system ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature: 16-20°C
- Humidity: 43-80 %
- Photoperiod: 12 hours cycle dark/lights maintained at a temperature
- Water (e.g. ad libitum): tap water

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approx. 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours, 7, 14, and 21 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

Slight Harderian discharge was observed in 1 animal on day 1 only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Testing of the test item for primary eye irritation in the rabbit showed that the substance is not irritating to eyes. The substance is not classifiable according to CLP criteria.

Executive summary:

In a primary eye irritation study equivalent or similar to OECD 405 of the test item was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits for 24 hours. Animals then were observed for 21 days/until reversibility has seen. Irritation was scored by the method of Draize.

All animals showed a slight redness of the conjunctivae. The mean score over 24, 48, and 72 h was 0.3 each for two rabbits and 0.7 for the third animal. Additionally the third rabbit showed a chemosis mean score of 0.3. No other signs of irritation have been observed.

In this study, the test item is not an eye irritant based on CLP criteria.